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Claims for Patent: 4,048,310

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Claims for Patent: 4,048,310

Title: Topical steroid formulation in form of lotion or cream
Abstract:Steroid formulations in the form of creams or lotions which are used as topical anti-inflammatory agents are provided wherein the steroid, such as 21-chloro-9.alpha.-fluoro-.DELTA..sup.4 -pregnene-11.beta.,16.alpha.,17.alpha.-triol-3,20-dione 16,17-acetonide, is at least partially dissolved in a ricinoleate vehicle such as castor oil.
Inventor(s): Chen; James Ling (East Brunswick, NJ), Battaglia; Jean M. (North Brunswick, NJ)
Assignee: E. R. Squibb & Sons, Inc. (Princeton, NJ)
Application Number:05/660,963
Patent Claims: 1. A composition for topical application in the form of a cream or lotion, comprising at least one steroid wherein said steroid is selected from the group consisting of 21-chloro-9.alpha.-fluoro-.DELTA..sup.4 -pregnene-11.beta., 16.alpha.,17.alpha.-triol-3,20-dione 16,17-acetonide; 21-chloro-9-fluoro-2',3'-dihydro-11.beta.-hydroxy-5'-propylpregna-1,4-dien o[16.alpha.,17-b][1,4]-dioxin-3,20-dione:dichloro methane solvate (1:1); and 9.alpha.-fluoro-11.beta., 16.alpha.,17,21-tetrahydroxy-pregna-1,4-diene-3,20-dione 16,17-acetonide, a ricinoleate vehicle in which said steroid is at least partially soluble, an emulsifier-thickener comprising a polyethylene glycol ether of a fatty alcohol, an oleaginous material or emollient, a preservative and water.

2. The composition as defined in claim 1 wherein said ricinoleate vehicle is castor oil.

3. The composition as defined in claim 1 wherein said steroid is present in an amount within the range of from about 0.005 to about 0.6% by weight of the composition said ricinoleate vehicle is present in an amount within the range of from about 0.5 to about 2% by weight of the composition, said emulsifier-thickener is present in an amount within the range of from about 1 to about 14% by weight of the composition, said oleaginous material or emollient is present in an amount within the range of from about 0.2 to about 8% by weight of the composition, said preservative is present in an amount within the range of from about 8 to about 50% by weight of the composition, and said water is present in an amount within the range of from about 30 to about 90% by weight water.

4. The composition as defined in claim 3 further including one or more antioxidants.

5. A composition as defined in claim 1 in the form of a cream wherein said steroid is all-in-solution, and said steroid is present in an amount within the range of from about 0.005 to about 0.6% by weight of the composition, said ricinoleate is present in an amount within the range of from about 0.5 to about 16% by weight of the composition, said emulsifier-thickener is present in an amount within the range of from about 5 to about 14% by weight of the composition, said oleaginous material or emollient is present in an amount within the range of from about 2 to about 8% by weight of the composition, said preservative is present in an amount within the range of from about 10 to about 50% by weight of the composition, and said water is present in an amount within the range of from about 30 to about 70% by weight of the compostion.

6. The composition as defined in claim 4 wherein said ricinoleate vehicle is castor oil.

7. A composition as defined in claim 1 in the form of a cream of the biphasic type, wherein said steroid is present in an amount within the range of from about 0.005 to about 0.6% by weight of the composition, said ricinoleate is present in an amount within the range of from about 0.5 to about 14% by weight of the composition, said emulsifier-thickener is present in an amount within the range of from about 8 to about 12% by weight of the composition, said oleaginous material or emollient is present in an amount within the range of from about 2 to about 8% by weight of the composition, said preservative is present in an amount within the range of from about 10 to about 50% by weight of the composition, and said water is present in an amount within the range of from about 30 to about 70% by weight of the composition.

8. The composition as defined in claim 7 wherein said ricinoleate vehicle is castor oil.

9. A composition as defined in claim 1 in the form of a lotion wherein said steroid is all-in-solution, said steroid is present in an amount within the range of from about 0.005 to about 0.6 % by weight of the composition, said ricinoleate is present in an amount within the range of from about 0.5 to about 16% by weight of the composition, said emulsifier-thickener is present in an amount within the range of from about 5 to about 14% by weight of the composition, aid oleaginous material or emollient is present in an amount within the range of from about 0.5 to about 6% by weight of the composition, said preservative is present in an amount within the range of from about 1 to about 50% by weight of the composition, and said water is present in an amount within the range of from about 50 to about 90% by weight of the compostion.

10. The composition as defined in claim 9 wherein said ricinoleate vehicle is castor oil.

11. A composition as defined in claim 1 in the form of a lotion of the biphasic type, wherein said steroid is present in an amount within the range of from about 0.005 to about 0.6% by weight of the composition, said ricinoleate is present in an amount within the range of from about 0.5 to about 14% by weight of the composition, said emulsifier-thickener is present in an amount within the range of from about 1 to about 5% by weight of the composition, said oleaginous material or emollient is present in an amount within the range of from about 0.2 to about 5% by weight of the composition, said preservative is present in an amount within the range of from about 8 to about 50% by weight of the composition, and said water is present in an amount within the range of from about 50 to about 90% by weight of the composition.

12. The composition as defined in claim 11 wherein said ricinoleate vehicle is castor oil.

13. A composition as defined in claim 1 wherein said steroid comprises 21-chloro-9.alpha.-fluoro-.DELTA..sup.4 -pregnene-11.beta., 16.alpha., 17.alpha.-triol-3,20-dione 16.17-acetonide.

14. A composition as defined in claim 1 wherein said steroid comprises 9.alpha.-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxypregna-1,4-diene-3,20 -dione 16.17-acetonide.

15. A composition as defined in claim 1 wherein aid oleaginous material is petrolatum, said emulsifier-thickener is polyethylene glycol fatty alcohol ether, and said preservative is propylene glycol.

16. A composition as defined in claim 1 further including econazole, nystatin, neomycin, gramicidin or mixtures thereof.

17. A composition as defined in claim 1 further including nystatin or econazole.

18. A composition as defined in claim 1 wherein said steroid comprises 21-chloro-9-fluoro-2',3'-dihydro-11.beta.-hydroxy-5'-phenylpregna-1,4-dien o[16.alpha.,17-b][1,4]dioxin-3,20-dione:dichloro methane solvate (1:1).

19. A method of treating dermatitis, which comprises administering topically an effecttive amount of a composition as defined in claim 1.

20. A method of treating dermatitis, which comprises administering topically an effective amount of a composition as defined in claim 3.

21. A method of treating dermatitis, which comprises administering topically an effective amount of a composition as defined in claim 5.

22. A method of treating dermatitis, which comprises administering topically an effective amount of a composition as defined in claim 7.

23. A method of treating dermatitis, which comprises administering topically an effective amount of a composition as defined in claim 9.

24. A method of treating dermatitis, which comprises administering topically an effective amount of a composition as defined in claim 11.

25. The composition as defined in claim 1 further including propylene glycol monostearate.
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